Question 1

Which of the following audits are generally more in depth than the other audits?

Options :

A : Regulatory inspection

B : 3rd party audit

C : 1st party audit

D : 2nd party audit

Answer: C

Question 2

What is the critical first step in the risk management process?

Options :

A : Risk analysis

B : Risk control

C : Risk evaluation

D : Risk management review

Answer: A

Question 3

According to EU MDR 2017/745, what is the meaning of the requirement to reduce risks ‘as far as possible’?

Options :

A : The reduction of risks as far as possible without considering the benefit-risk ratio

B : The reduction of risks as far as possible even with adversely affecting the benefit-risk ratio

C : The reduction of risks as far as possible without adversely affecting the benefit-risk ratio

D : The reduction of risks as far as possible without considering regulatory compliance risk

Answer: C

Question 4

Brazilian device classification rules are similar to those of ______________.

Options :

A : Japan

B : USFDA

C : EU

D : China

Answer: C

Question 5

If resterilization is indicated due to a process nonconformity, the effect of resterilization on the product and packaging should have been ______________.

Options :

A : Determined in the validation study to allow such reprocessing

B : Determined in the verification study to allow such reprocessing

C : Design master record (DMR)

D : Recorded on product label

Answer: A